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A Study of Treprostinil and a New Formulation of LY900014 in Healthy Japanese Participants

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Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Treprostinil
Drug: Insulin Lispro
Drug: LY900014
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02770521
16071
I8B-JE-ITRK (Other Identifier)

Details and patient eligibility

About

The aims of this study are to evaluate:

  • The safety and tolerability of a single dose of treprostinil given subcutaneously (as an injection just under the skin)
  • The pharmacokinetic profile (how the body absorbs, breaks down, and gets rid of) of a single subcutaneous dose of a new LY900014 formulation in healthy Japanese participants.

The study has two parts. Participants may only enroll in one part.

Enrollment

23 patients

Sex

All

Ages

20 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Overtly healthy Japanese
  • Body mass index (BMI) 18.5 - 25 kilograms per square meter (kg/m²)
  • Fasting plasma glucose ≥71 milligrams per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]) and <108 mg/dL (6.0 mmol/L) (Part B only)
  • Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study

Exclusion criteria

  • Are currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
  • Have participated in a clinical trial involving an investigational product within the 30 days before study entry.
  • Have previously completed or withdrawn from this study or any other study investigating treprostinil or LY900014, and have previously received the investigational product
  • Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

23 participants in 4 patient groups, including a placebo group

Treprostinil (Part A)
Experimental group
Description:
Treprostinil administered as a single subcutaneous (SC) bolus injection.
Treatment:
Drug: Treprostinil
Placebo (Part A)
Placebo Comparator group
Description:
Placebo administered as a single SC bolus injection.
Treatment:
Drug: Placebo
LY900014 (Part B)
Experimental group
Description:
LY900014 (test) administered as a single SC bolus injection.
Treatment:
Drug: LY900014
Insulin Lispro (Part B)
Active Comparator group
Description:
Insulin lispro (reference) administered as a single SC bolus injection.
Treatment:
Drug: Insulin Lispro

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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